Development and Validation of RP-HPLC Method for Simultaneous Estimation of Eperisone Hydrochloride and Diclofenac Sodium in Bulk and Pharmaceutical Dosage form

A simple, rapid and precise Reverse Phase High Performance Liquid Chromatographic method was developed for simultaneous estimation of Eperisone hydrochloride and Diclofenac sodium in pharmaceutical dosage form by reverse phase Pinnacle DB C-18 column (250 mm, 4.6 mm, and 5 μm). The sample was analyzed using 50mM ammonium acetate buffer containing 0.2% triethylamine (pH-4.0 adjusted with glacial acetic acid): Acetonitrile (40:60, v/v), as a mobile phase at a flow rate of 1.0 ml/min. and detection at 273 nm. The retention time for Eperisone hydrochloride and Diclofenac sodium was found to be 3.07 min and 5.56 min, respectively. The linearity of developed method was achieved in the range of 10-100 μg/ml for Eperisone hydrochloride and 10-100 μg/ml for Diclofenac sodium. The method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantitation, robustness and ruggedness as per ICH guidelines.